Breast CancerPhase 3NCT00547989
Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
A Phase 3 study testing standard anaesthesia (bupivacaine), additional pvb (ropivacaine) and elastomeric disposable infusion pump and additional pvb (ropivacaine) in people with Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- standard anaesthesia (bupivacaine), additional pvb (ropivacaine) and elastomeric disposable infusion pump and additional pvb (ropivacaine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2006to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Extended mamma surgery one-sided
- ASA class I and II
Who cannot join
- All contra indications for local anaesthesia
- Coagulation disorders
- Infection
- Allergic reactions
Trial locations and contacts
1 site in 1 country.
About this study
Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.
Read the detailed description
Usually breast tumour surgery in the Academic Hospital Maastricht is performed under general anaesthesia. Perioperative pain management consists of paracetamol and naproxen preoperatively, opioids during surgery and local wound infiltration at the end of surgery with 10cc Bupivacaine 0.25%. Postoperative pain management consists of paracetamol, occasionally combined with Naproxen, and if necessary Piritramide 0.2 mg/kg i.m.
Alternatively there is the possibility to perform breast surgery under a thoracic paravertebral block (PVB) with or without general anesthesia.
A PVB according to Eason and Wyatt (1) can be performed preoperatively with insertion of an end-hole catheter T3-T4. With this technique we expect a better pain relief postoperatively.
- Conditions
- Breast Cancer
- Being tested
- standard anaesthesia (bupivacaine), additional pvb (ropivacaine) and elastomeric disposable infusion pump, additional pvb (ropivacaine)
- Keywords
- ASA class I and II
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard anaesthesia (bupivacaine)Drug
Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required
additional pvb (ropivacaine) and elastomeric disposable infusion pumpDrug
Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.
additional pvb (ropivacaine)Drug
Patients in group 1 will receive PVB with ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | control Receives: Drug: standard anaesthesia (bupivacaine) |
| 2 | Experimental | PVB with ropivacaine and postoperative pump 5ml/h Receives: Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump |
| Experimental 1 | Experimental | PVB with ropivacaine, 10 patients included but not analysed Receives: Drug: additional pvb (ropivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of unplanned admissions and reduction of VAS score.
Measured: one week
Secondary outcomes (1)
to determine the safety and performance (efficacy) of the technique and the investigational product.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Bouman, MD, Principal investigator, azM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547989
- Sponsor's protocol ID
- MEC 05-105.5
- Status last verified
- Jun 2014
- First submitted
- 18 Oct 2007
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
- ClinicalTrials.gov ID
- NCT00547989
- Acronym / sponsor ID
- MEC 05-105.5
- Conditions
- Breast Cancer
- Keywords
- ASA class I and II
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.
Detailed description
Usually breast tumour surgery in the Academic Hospital Maastricht is performed under general anaesthesia. Perioperative pain management consists of paracetamol and naproxen preoperatively, opioids during surgery and local wound infiltration at the end of surgery with 10cc Bupivacaine 0.25%. Postoperative pain management consists of paracetamol, occasionally combined with Naproxen, and if necessary Piritramide 0.2 mg/kg i.m.
Alternatively there is the possibility to perform breast surgery under a thoracic paravertebral block (PVB) with or without general anesthesia.
A PVB according to Eason and Wyatt (1) can be performed preoperatively with insertion of an end-hole catheter T3-T4. With this technique we expect a better pain relief postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: standard anaesthesia (bupivacaine)control |
| 2 | Experimental | Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pumpPVB with ropivacaine and postoperative pump 5ml/h |
| Experimental 1 | Experimental | Drug: additional pvb (ropivacaine)PVB with ropivacaine, 10 patients included but not analysed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Extended mamma surgery one-sided
- ASA class I and II
Key exclusion criteria (4 listed)
- All contra indications for local anaesthesia
- Coagulation disorders
- Infection
- Allergic reactions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard anaesthesia (bupivacaine)Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required | Drug | 1 |
| additional pvb (ropivacaine) and elastomeric disposable infusion pumpPatients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h. | Drug | 2 |
| additional pvb (ropivacaine)Patients in group 1 will receive PVB with ropivacaine | Drug | Experimental 1 |
Primary outcome
reduction of unplanned admissions and reduction of VAS score.
Time frame: one week
1 secondary outcome
to determine the safety and performance (efficacy) of the technique and the investigational product.
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Bouman, MD principal investigator
azM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing standard anaesthesia (bupivacaine), additional pvb (ropivacaine) and elastomeric disposable infusion pump and additional pvb (ropivacaine) in people with Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of unplanned admissions and reduction of VAS score. (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.